Boris Johnson has sought to reassure people about the safety of the Oxford/AstraZeneca Covid vaccine as a trial in children was paused while regulators investigate rare reports of blood clots, largely in younger women.
The prime minister urged the public to take the jab when it is offered, while scientists stressed the side-effects were extremely rare and the benefits of protection against coronavirus were great.
Some UK drug safety experts believe there could be a causal link between the AstraZeneca jab and rare blood clotting events including cerebral venous sinus thrombosis (CVST).
But they said vaccination programmes must continue, with risk mitigation for women under 55. Doctors have already been alerted to CVST symptoms, which include headache, blurred vision and fainting.
Oxford University is running a trial in more than 200 children and young people aged six to 17 to see whether they could benefit from the AstraZeneca jabs. The trial was paused on Tuesday as a precautionary measure in response to investigations by the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK and the European Medicines Agency (EMA), a university spokesperson said. The regulators are considering whether any action should be taken, with statements expected within days.
The Oxford spokesperson added: “While there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopenia that have been reported in adults, before giving any further vaccinations in the trial.”
On a visit to the AstraZeneca manufacturing plant in Macclesfield, Cheshire, on Tuesday, Johnson said that getting the vaccine was “the key thing”. The jab has been given to more than 18 million UK adults with just
30 rare blood clotting cases reported, and seven deaths.
“The best thing people should do is look at what the MHRA say, our independent regulator – that’s why we have them, that’s why they are independent,” said Johnson, who has received a first dose of the vaccine himself. “Their advice to people is to keep going out there, get your jab, get your second jab.”
Prof Saad Shakir, the director of the
drug safety research unit (DSRU) at Southampton University, said on Tuesday that the evidence accumulated in Europe and the UK of links between the vaccine and the rare blood clots “is consistent with causality”.
While the dangers of coronavirus were so great that vaccination must not stop, he said, measures should be put in place to reduce any extra risk to women under the age of 55, who seemed to be most affected. The DRSU has shared its analysis with the regulators.
Earlier on Tuesday,
the EMA denied it had already established a causal connection between the vaccine and the clots, after a senior official from the agency said there was a link. Marco Cavaleri, the EMA’s head of vaccines, had earlier told Italy’s Il Messaggero newspaper that in his opinion
“we can say it now, it is clear there is a link with the vaccine … but we still do not know what causes this reaction”.
More:
https://www.theguardian.com/world/2...ausal-link-to-rare-blood-clots-say-uk-experts